New Amendment May Help Save Compounded Drugs

Please help us get Sen. David Vitter’s critical amendment passed! Action Alert!
As you know from our continuing coverage, the FDA has been issuing rules to implement the Drug Quality and Security Act (DQSA). This legislation was passed by Congress in 2013 in response to a meningitis outbreak in 2012 involving a single bad actor—a compounding facility in Massachusetts about whom the FDA had received numerous complaints (though the agency took no action other than sending a warning letter to the facility).
Panicked legislators nearly destroyed compounding as an alternative to conventional drugs—something that would eliminate competition for the biggest drug companies, which is why the DQSA seems to have garnered support from Big Pharma allies at the FDA. We were able to amend the law and help save compounding, but some very bad provisions remain. As a result, ANH-USA has been closely monitoring the FDA as it releases drafts of its new rules and guidance documents pertaining to this law.
Compounding, in many cases, is the only way for consumers to access a number of important natural medicines, or to take those medicines in more natural ways. For example, a number of hormones should not be taken orally, but only transdermally. Drug companies and the FDA simply ignore this.
Compounding is important for other reasons as well. In particular, it allows doctors and pharmacists to create medications that are the exact strength, dosage, and ingredient mix best suited to treat an individual patient. Perhaps the medication needs to be gluten free or in lower dosages. We are all different; medicine should never be one-size-fits-all.
We have two main points of contention with the new FDA rules on compounding:

Office Use

“Office use” is when a physician, in his or her office or other treatment area, administers a compounded medicinal preparation directly to a patient for the immediate treatment of a problem. In these instances, a doctor would need to have a reserve supply of the compounded drugs on hand. This enables doctors to provide immediate relief to ailing patients who come into their office, or to have a ready supply for patients whom they have a long history of treating.
For decades, the regulation of “office use” was left up to state pharmacy boards, and most state boards allowed physicians to keep a supply of compounded drugs on hand without prescriptions, recognizing that patients’ well-being depended on it. This changed with the passage of the DQSA.
Congress’s intent was to give the FDA clearer authority over compounding, and it did so by enacting an amended version of Section 503(a) of the Food, Drug, and Cosmetic Act. Congress essentially told the FDA to start enforcing the rules that were already on the books; the DQSA is completely silent on the issue of office use. The FDA, however, immediately indicated it would apply the DQSA in a way that would eliminate office use.
This apparently came as a surprise to some legislators, who wrote a letter to the FDA reiterating that it was Congress’s intent to leave office use up to the states. In a written response, the FDA was resolute in its decision: “A compounding pharmacist may not dispense compounded medications for office use, but rather, must obtain a prescription for an individually identified patient.”
As you might guess, this has caused a tremendous amount of confusion in the medical community and among many state pharmacy boards that have historically allowed office use. Fearing retaliation from the FDA, pharmacists are now reluctant to supply doctors with compounded drugs for office use.
A new amendment from Sen. David Vitter (R-LA)—the Saving Access to Compounded Medications for Special Needs Patients Act—clears up the confusion by amending 503(a) to unambiguously allow office use and preserve the ability of doctors to promptly and effectively treat their patients.

Interstate Commerce and the Memorandum of Understanding

Traditional compounding pharmacies are only allowed to ship 5% of their sales per month out of state, unless they enter into a memorandum of understanding (MOU) with the FDA. The law does not define the limit once a pharmacy has entered into an MOU, but the FDA has created a threshold of 30% in their new rules.
These limits are completely arbitrary and having nothing to do with the safety of consumers. If 30% is safe, why isn’t 10%, or 20%? Is 31% suddenly unsafe for consumers? Is 50%? Additionally, how can a pharmacy be sure that it has not or will not exceed any specific percentage until the end of the month, when it’s too late to do anything about it?
In addition, many states will refuse to sign an MOU with the FDA because by doing so they agree to assume full regulatory responsibility for the pharmacies. In all likelihood, the FDA designed the MOU offer in a way that they knew would be rejected. In our opinion, the objective behind all of this is to shut down compounding simply because it threatens Big Pharma profits, and Big Pharma funds the FDA.
Sen. Vitter’s amendment addresses this issue by stipulating that, if a compounded medication is for an individual patient, there will be no cap on the amount that a pharmacy can ship interstate. It also stipulates that the MOU will not create unfunded regulatory burdens for states, which makes the prospect of entering into an MOU less onerous for states.
The amendment doesn’t fix all the issues that have arisen with new compounding regulations, but it takes a number of strong steps to address some of the worst problems. If passed, this amendment would go a long way in preserving consumer access to important compounded medications.Action Alert! Write to your senators and urge them to support the Vitter amendment, which would take major steps to preserve consumer access to compounded medications. Please send your message immediately.

34 responses to “New Amendment May Help Save Compounded Drugs”

We Americans are loosing our rights because certain leaders are allowing corporations to put PROFIT over the HEALTH and SAFETY of American Citizens.
This is happening because
corporations give millions of dollars to politicians who in turn make it possible for the corporations to do what ever they want to do without any regard for the safety of people or the environment in our country and around the world.
WHAT KIND OF LEADERSHIP IS THIS? !!!!!!!!
It is the RIGHT of all American citizens to live in a country NOT RULED BY CORPORATE GREED.
When our rights get taken away in the name of freedom, that weakens the democracy of the United States.
These leaders keep trying to
TAKE AWAY OUR HEALTHCARE
TAKE AWAY OUR SOCIAL SECURITY.
TAKE AWAY OUR PENSIONS.
BLOCK THE RIGHT TO VOTE TO MAKE IT EASIER FOR THEM TO WIN ELECTIONS.
FORCE MIDDLE CLASS AMERICANS TO PAY OUT OF OUR OWN POCKETS THE TAX MONEY THAT CORPORATIONS SHOULD BE PAYING.
We are even losing our right to
Live in a clean and safe environment
Because corporations are being allowed to pollute are planet.
They are
Poisoning our beaches and oceans,
poisoning the air we breath,
poisoning the food we eat,
poisoning the water we drink and
poisoning the land we live on.
This is just the tip of the iceberg.
There are so many of our rights being trampled on that there isn’t enough space on my computer to list them all.
And as corporations demand to get richer, our leaders try to take more of our rights away.
Lately I have been seeing more statements on the internet from people who are saying that If our rights continue to be taken from us then it could eventually lead to another civil war in the United States.
That frightens me.
Hitler came to power in a democracy with a highly liberal constitution, and in part by using democratic freedoms to undermine and then destroy democracy itself while Germany’s corporate leaders got very rich.
This might sound like another one of those annoying Hitler comparison.
BUT the corporate domination that is taking place in our country right now
Is very similar to the change that took place in Germany and it is making me nervous.
We are very lucky that
SENATOR BERNIE SANDERS, FORMER GOVERNOR MARTIN O’MALLEY AND SENATOR RAND PAUL ARE FIGHTING AGAINST THE CORPORATE CORRUPTION IN OUR COUNTRY AND ALL THREE OF THEM ARE RUNNING FOR PRESIDENT OF THE UNITED STATES.
It would be very helpful to our country if all of us would make it a top priority to support these three courageous leaders and do everything we can to URGE ALL OF OUR LEADERS to put an end to this outrageous corporate take over of the United States before it becomes much harder to stop.
Sincerely
Dale Boyco

Rand Paul is one of those clowns that is Pro-Extinction; Just look at his attempt to gut the ESA so him and his rich oil industry friends can murder all the endangered species they want, including humans. Don’t support petty crooks who lie to your face, it only makes you look dumb.
You shouldn’t trust ANY politicians, I am even skeptical of Bernie sanders.
I won’t be taking anyone’s side except the planet and Mother Nature.
To me, humans are trash. Nothing but abusive and vile, mean, cruel barbarians.

I think Rand Paul is the only politician out there talking about restoring the Constitution – as well as ending the war on drugs/people. He wants to gut a bureaucratic program ESA that is designed to give Washington more power. The Feds want you off the land – that way you won’t be able to grow hemp/food on it. If you could grow hemp for food, fuel, fiber & medicine – you wouldn’t need to rely on the globalists anymore. BTW if ESA was serious – we’d all be growing hemp as hemp breathes in CO2 and produces 4x the oxygen as other trees. Hemp For Victory!

I agree with so many things you said, except I think that Rand Paul has NO merit whatsoever (love Bernie, though). Also, it seems like you want compounding pharmacies to start making bulk compounds again, which is how hundreds of people died from contaminated injectables a few years ago. A compounding pharmacy does not have the equipment, expertise or oversight to be running a full scale drug manufacturing plant. When they do end up putting out contaminated medications – which it’s only a matter of time – it will be virtually impossible to figure out which patients received the products that need to be recalled. We aren’t losing rights when we are protected from unsafe products. The only reason compounding pharmacies want to make bulk compounds is to make more money – it’s not because it serves any purpose for patients.

Doctors offices do not keep prescription drugs on hand to dole out to patients, and they should not keep compounded drugs on hand either. This is the sort of behavior that resulted in the deaths of many people from contaminated compounded drugs a few years ago. It was not an isolated case – there were several compounding pharmacies making up hundreds of compounds and sending them to nursing homes, doctors offices, surgical facilities, etc…. I am a big fan of compounded drugs, but all three of the compounding pharmacies I used in the previous ten years were closed down – one due to billing fraud, and two due to improper compounding of drugs. One was compounding medication for eyes with no means to sterilize it. The other repeatedly sent patients home with either the wrong ingredients, or vastly different doses than ordered, in their compounded drugs, and they couldn’t account for where specific drugs came from or where they went. For some reason, fraud, incompetence, carelessness and lack of concern for patients seems to run rampant in compounding pharmacies – probably because they had very little supervision for a very long time. I’ve found a compounding pharmacy that I like, and I hope it works out OK, but I’d prefer to see continued scrutiny to prevent the abuses that took place in the past.

Doctors do indeed keep prescription drugs in their offices as these ‘samples’ are often provided to the doctors from the pharmaceutical representative. While I understand your resistance due to your past experience, we must first vet our providers (compounding pharmacies) as to be certain of their quality and integrity. I have used one compounding pharmacy for nearly 6 years and they are a quality institution.

Doctors do occasionally give out samples of drugs that were given to them free by the pharmaceutical industry specifically for this purpose. The drugs are in very small containers and have never been opened before. This is not necessary, but I don’t see anything wrong with it.
Compounded drugs are a different story. Drugs that were originally packaged in a sterile environment and in a sterile container by a drug company are opened by the compounding pharmacist, touched, mixed with other drugs, lotions and inert ingredients that have also been opened from their original containers, and the resulting product is placed in a non-sterile container. There is a new level of risk for contamination here, since most compounding pharmacies do not have the same quality sterilization equipment or work area as a drug company. Drugs produced by major drug companies are made in large areas that were specifically built for the manufacture of drugs – these facilities are cleaned and sterilized rigorously, have high powered air filtration devices, fume hoods, and they undergo frequent inspections. You can generally watch the compounding pharmacist do their compounding behind the counter of the pharmacy, in areas that were not designed for that task – on countertops or desk tops that are often dusty, have lots of untrained people walking around, possibly have mold in the air from water leaks, and have no real specialized equipment. The conditions and areas where compounding is done are not monitored or inspected by anyone.

I have toured many compounding laboratories. The ones that produce sterile medications (a small percentage do these specialized medications which are eye drops,injections, and IV’s) are required to have sterile rooms that conform to USP 797 codes. They are inspected by multiple entities- the State Board of Pharmacy, the FDA, and if they are compounding medications for hospitals then the hospitals themselves also do inspections. All their equipment, procedures and personnel must meet all the stringent requirements of government mandated USP 797.

I’ve seen these things being made in cubby holes behind the counter of the compounding pharmacy without a dedicated work area, hood or special equipment, so if there are indeed laws that they must use sterile rooms for these preparations, the ones I’ve gone to clearly are not following the rules.

Sterile medications must be made in a USP 797 sterile environment – non-sterile medications like capsules and creams, etc. must be made in a USP 795 compliant environment. If you have seen otherwise then they are not following pharmacy requirements and face serious consequences when they are inspected. It is important to know who you are doing business with, as in all professions, some are definitely superior to others.

One of my previous compounding pharmacies – the second one I had ever gone to – was closed down two years ago with 68 indictments against them, including making eye salves without any means whatsoever to sterilize the salves. This had been going on for more than a decade. I had started using HRT creams made at a compounding pharmacy when we lived in Texas, and had great results with them. When we moved, I went to the only compounding pharmacy in our new location. With the new compounding pharmacy, I never had any of the positive results I’d had from the previous compounds. I had reactions from two HRT creams and discovered both were completely messed up – one that resulted in my testosterone level being 47 times normal, even though I had started using only a quarter of the recommended dose when I noticed some alarming changes, and one compound that was supposedly progesterone that, when I was tested, resulted in zero progesterone and a DHEA level that was off the charts. Both times the pharmacist claimed I must be using the creams wrong. I read later that compounders sometimes substitute DHEA for progesterone because it’s cheaper and they thought people wouldn’t notice. Several of the indictments against this pharmacy had to do with improper use and distribution of testosterone, and there were many instances of incorrect ingredients and incorrect doses in their compounds. While I’m sure there are all sorts of recommendations for compounding pharmacists, any maybe even requirements, the problem has been that these recommendations or requirements were not enforced. There was virtually NO oversight, and consequently compounding pharmacies became overrun with people who were either committing fraud, or who were just not all that concerned about doing things right or following rules. I think we need to demand that compounding pharmacies meet the same standards as other pharmacies, and that they undergo the same scrutiny, inspections and oversight as drug manufacturers. I’m using HRT from a new compounding pharmacy now and while there is definitely an improvement, I still don’t have all the positive results that I had with the original compounds from the pharmacy in Texas. I asked about third party testing of the ingredients and was assured that they do it, but he wasn’t able to show me proof. I noticed compounding being done under a fume hood that did not appear to be operational, and there was construction going on in the building next store, resulting in lots of visible dust in the air. I’ve heard good things about this compounding pharmacy, so I’m giving them the benefit of the doubt, but so far I’m not impressed with them, either. BTW, I used to work in a lab, so I know what a clean work space should look like. So far I’ve never seen one in a compounding pharmacy.

The same FDA that is allowing a toxic monopoly on life itself and doesn’t even safety test the majority of what it approves. Just saying, I mean, it gives reason as to why so many compounding centers were getting contaminated. I doubt the FDA even does any inspections at all. The entire industry is running on a “voluntary” system, the fox guards the hen-house.

Drugs, both mass-produced and compounded are used in the doctors’ offices ALL THE TIME. Some of these medications are ones that need the expertise of the doctor to apply and are not intended to be sent home with the patient which is why they are used in the office under the supervision of a doctor. A doctor never knows what will come through the door and needs to be prepared for anything, that is why they MUST have these medications on hand for immediate use when needed.

That’s just not correct. Please provide ONE example of a compounded medication or prescription medication that a doctor would need to keep in their office. I have never once received any sort of medication – prescription or compound – that was given to me in the doctors office. Doctors give prescriptions and patients pick up prescriptions at their pharmacies.

Topical anesthetics for wound application and pre-stitches numbing, wart removing medications which are not allowed to be used by the patient at home (there are several of these), preparations applied to the cervix for treatment of HPV (most patients couldn’t do this themselves!), vitamin and supplement IV bags or injectables – like vitamin C, vitamin B12 and I could name so many other medications! It happens all day long, everyday……

Preparations applied to the cervix for HPV treatment, anesthetics for stitches, wart removal and other such medications do not have to be compounded. In fact, all these should be used from sterile, unopened vials.

Except that some of these medications are not being produced and therefore the only way to get them is to have them compounded. Drug manufacturers only manufacture things that are needed on a large enough scale to be mass produced at a profit. If this isn’t the case, then the only way to get those particular items is to have them custom made on a case by case basis.

There are no anesthetics that have to be compounded. There are no wart medications that have to be compounded. Anything that has to be compounded should be compounded for a specific patient. Compounding pharmacists are not drug manufacturers. Drug manufacturers have to be inspected and submit to a variety of testing and inspections that compounders do not.

Again, there are no compounded drugs needed in a doctors office. Compounded drugs should be specially compounded according to the needs or desired dosage for each specific patient. Drugs used for injection should come from unopened glass vials.

Read the last three paragraphs.
But basically it is the same old story: Criminal cabal regulatory “agencies” take the initiative to protect corporate profits instead of public health or environment, etc etc.
Just more crooks trying to rig the system for their own/their benefactors gain.
That is all the US is now, a bunch of pathetic financial crooks rigging the system to gain more for them petty selves. Sad and disgusting.

Agreed. Couldn’t have said it any better. However, I don’t think it matters anymore what the Criminal cabal regulatory “agencies” think or do. The genie is out of the bottle…. CBD oil and the cannabis sativa plant will revolutionize healthcare – hopefully in the near future.

Well the problem is these are the goons who get to make the rules and they are in cahoots with the crooks who attempt to enforce them. The entire system already poisons and murders us, so I disagree when you say that it doesn’t matter. It does matter what these goons say because they are the ones who tell all the pill pushers what they can or can’t do, which means they won’t be able to tell you the information they should or provide the care you properly deserve ~ by “dictation” of this organization, the AMA.

For the 11 million or so who have no safe asthma inhalers anymore as we have non allegic types, hundreds of dollars of expensive inhalers can ad have been replaced by stand alone pharmacies compounded a synthetic steroid an cromyln to stabilize bronchiospasms I hae use these for several years and the cost is only about @$25 a month vs $500 or so. I have to do is put a few preservative free drops in the bubble cup of distilled water attached to my liquid oxygen tank. I am doing better with a unite amount 24/7 . personally I do not see why the pharmacist has to compound and I just get the bottle prepackaged but pharmaceutical companies will not make the money off of a few drops? I pray not… I have had 4 doctors prescribe this after the first who did so when I ran out of the CFC propellant inhalers and nothing was safe for me and many others to use. Linda joy Adams

And guess what, on-top of that the only reason you have asthma is from the toxic chemicals they use on you!
US = Give you health problems, make you pay money for health problems, keeping you down and out so some jerk can make more money that has no value.
That is just how sad and pathetic the corporate crooks running this sideshow are.

In a nutshell, the systems only intention is to sabotage people and planet for industrial corporate gain.
That means your health for their profits, your happiness, your prosperity, your freedoms and even your life.
They’ve poisoned the food, the air, the water, the ground, the skies, and are even destroying the natural world with genetically engineered organisms! All for Corporate Profits of a Value-less Currency. The U.S. is so awful and braindead that the dumb crooks put in place after JFK’s murder only care about MONEY over LIFE ITSELF. Such Heresy against nature and life on this planet IS CRIMINAL and will be dealt with ~~ with BRUTAL DISREGARD to their society and to their concepts/perceptions. You think you own this planet, but it is this planet that owns you and all you have made and in an instant it will obliterate it all and have NO remorse. You humans own nothing but your own thoughts and you’ve gone out of your way to defeat even those. Well, once you have defeated yourselves how can you really say you’ve won anything at all?
A people Long Divided are Soon to Fall.

You can send it to your local Schooling Institutions and hope they provide you with a better Education. It would probably be best if you put the money towards Community College and took Computer classes or perhaps Civics so that you actually knew ‘wtf’ you were doing with your life.
The Societal system you pay taxes to maliciously poisons you with said taxes and you want to worry more about a deletable internet file that causes no harm at all. Your priorities are skewed and you need to be informed on what the real problems in the world are, because, they certainly are not Cookies.

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